Transfemoral amputee, healthy subjects wearing the ILK using an L-shaped socket
Conditions
Interventions
Study is designed as an A-B-A study, in which A is the subject's daily use prothesis and B the Reboocon ILK.
Sponsors
Universiteit Twente
Biomedische werktuigbouwkunde
Drienerlolaan 5
7522 NB Enschede
Eligibility
Inclusion criteria
Inclusion criteria: - Aged between 18 and 65. - Weight below 100 kg. - Body length between 1.51 and 1.95 m. - Unilateral transfemoral amputation or knee disarticulation. - Functional level from K2 to K4 o Level 2: The patient has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator. o Level 3: The patient has the ability or potential for ambulation with variable cadence. Typical of the community ambulatory who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion. o Level 4: The patient has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete. - Able to perform low to moderate vigorous physical activity for a duration of 3 hours including breaks. - At least one year after amputation. - Willing to commit to a series of 1 or 2 training sessions of approximately 1.5 hours to get adjusted to the IntelLeg Knee. - Current prosthesis is a passive microprocessor controlled knee.
Exclusion criteria
Exclusion criteria: - Not willing to consent to participate in the study. - Other musculoskeletal problems influencing walking ability. - Stump problems/bad socket fitting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Self-selected preferred walking speed - Fastest walking speed - Metabolic energy consumption during walking at comfortable walking speed - Borg-Scale after completion of each movement activity - Relevant subscores of the Prosthesis Evaluation Questionnaire (Usefullness, Appearance, Sounds, Ambulation) - Hill Assessment Index - Stair Assessment Index - Time to complete the L-test - Time to complete the Four Square Step Test | — |
Secondary
| Measure | Time frame |
|---|---|
| - Data from all sensors of the IntelLeg Knee - Classification accuracy of intent recognition algorithms using the IntelLeg Knee - Joint angles - Muscle activity | — |
Outcome results
None listed